Tuesday, July 25, 2017 at 10 a.m. PT / 1 p.m. ET

These two leading topic experts will be discussing significant ways to unlock the mysteries of the human microbiome; how it affects our health, the immune system, and why it is so important to protect it.

As part of the Centers for Disease Control and Prevention (CDC) efforts to protect patients and slow antibiotic-resistance, the CDC is investing in research to discover and develop new ways to prevent antibiotic-resistant infections.

Your digestive, or gastrointestinal (GI), tract is a long, muscular tube that runs from your mouth to your anus. It’s about 30 feet long and works with other parts of your digestive system to break food and drink down into smaller molecules of nutrients. The blood absorbs these and carries them throughout the body for cells to use for energy, growth, and repair.

With such a long GI highway, it’s common to run into bumps in the road. About 60 to 70 million Americans are affected by digestive diseases, like gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS). GERD happens when your stomach acid and/or contents come back up into your esophagus (swallowing tube) or throat. This causes uncomfortable symptoms like heartburn and indigestion. IBS is a group of symptoms that includes pain in the abdomen and changes in bowel habits. People with IBS may have constipation, diarrhea, or both. Many more people have other digestive problems, like bloating and stomach pain.

“There are many factors that can impact gut health,” says Dr. Lin Chang, a GI expert at the University of California, Los Angeles. How your body’s built, your family and genetic history, how you manage stress, and what you eat can all affect your gut.

“I see a lot of lifestyle-related GI issues, and there are often no quick fixes for that,” she says. “In general, people do well when they create a more routine schedule, eat a healthy diet and smaller more frequent meals, add in some exercise, and get a good amount of sleep.”

Chang studies the connection between stress and IBS. Her research group has found that people who have early life stress are more likely to develop IBS. “However, this increased risk for IBS went down when people confided in someone they trust about the stress they experienced,” she explains. “Finding healthy ways to manage stress is important for GI health, and your health overall.”

What you eat can help or hurt your digestive system, and influence how you feel. “Increasing fiber is really important for constipation,” says Chang. “Most Americans do not eat a lot of fiber so you have to gradually increase the fiber in your diet. Otherwise you might get gas and more bloating, and won’t stick with [the changes].”

Chang says you should eat at least 20–30 grams of fiber a day for constipation. You can spread out your fiber in small amounts throughout the day. Start with small servings and gradually increase them to avoid gas, bloating, and discomfort.

Try to eat fruits and vegetables at every meal * cooked well for post-C.diff. infection patients until tolerated.

A variety of fruits, vegetables, whole grains can provide a healthy mix of different fibers and nutrients to your diet. An added benefit is that the more fiber and whole foods you eat, the less room you’ll have for less healthy options.

But some fiber-rich foods, called high FODMAP foods, can be hard to digest. Examples include certain fruits and vegetables, dairy products, and wheat and rye products.

If you have IBS, your doctor may recommend a diet low in FODMAPS.

Researchers are coming to understand the complex community of bacteria and other microbes that live in the human GI tract. Called gut flora or microbiota, these microbes help with our digestion.

But evidence has been growing that gut microbes may influence our health in other ways too. Studies suggest that they may play roles in obesity, type 2 diabetes, IBS, and colon cancer. They might also affect how the immune system functions. T

his can affect how your body fights illness and disease.

Recent studies have found that microbes’ effects on the immune system may impact the development of conditions such as allergy, asthma, and rheumatoid arthritis.

You might have heard that probiotics—live microbes that are similar to those found in the human gut—can improve your gut health. These are also called “friendly bacteria” or “good bacteria.” Probiotics are available in dietary supplements and in certain foods, such as yogurt.

There is some evidence that probiotics may be helpful in preventing diarrhea associated with antibiotics and improving symptoms of IBS, but more needs to be learned.

Researchers still don’t know which probiotics are helpful and which aren’t. They also don’t know how much of the probiotics people would have to take or who would most likely benefit from them.

Certain food additives called emulsifiers are something else that may affect your gut health. Emulsifiers are added to many processed foods to improve texture and extend shelf life. But studies show they can affect our gut flora.

“Our work and other research indicate that emulsifiers and other food additives can negatively impact the microbiota and promote inflammatory diseases,” says Georgia State University’s Dr. Andrew Gewirtz. His group has been studying the relationships between food additives, gut bacteria, and disease in mice. The team also plans to examine how different food additives may affect people.

Based on what his team and others have found, Gewirtz advises, “The take home message: Eat a balanced diet and less processed foods.”

“The GI system is complicated and such an important part of our health,” Chang says. “It takes a real partnership between patient and doctor to get to the root of issues. Everyone has to find a healthy routine that works for them.”

She encourages you to take an active role in finding a doctor who makes you feel comfortable. The right doctor will listen carefully to your health history and symptoms. You can help keep your gut in check by talking with your doctor and—together—making the right choices for you.

To Learn More About FODMAP, Probiotics, Prebiotics, C. difficile and post-C.difficile nutrition

join Karen Factor, RD every 3rd Thursday each month for free sessions. Sign up today through

Health and Disease Imprinted in the Time Variability of the Human Microbiome

Abstract

The animal microbiota (including the human microbiota) plays an important role in keeping the physiological status of the host healthy.

Research seeks greater insight into whether changes in the composition and function of the microbiota are associated with disease.

We analyzed published 16S rRNA and shotgun metagenomic sequencing (SMS) data pertaining to the gut microbiotas of 99 subjects monitored over time.

Temporal fluctuations in the microbial composition revealed significant differences due to factors such as dietary changes, antibiotic intake, age, and disease.

This article shows that a fluctuation scaling law can describe the temporal changes in the gut microbiota. This law estimates the temporal variability of the microbial population and quantitatively characterizes the path toward disease via a noise-induced phase transition. Estimation of the systemic parameters may be of clinical utility in follow-up studies and have more general applications in fields where it is important to know whether a given community is stable or not. IMPORTANCE The human microbiota correlates closely with the health status of its host. This article analyzes the microbial composition of several subjects under different conditions over time spans that ranged from days to months. Using the Langevin equation as the basis of our mathematical framework to evaluate microbial temporal stability, we proved that stable microbiotas can be distinguished from unstable microbiotas. This initial step will help us to determine how temporal microbiota stability is related to a subject’s health status and to develop a more comprehensive framework that will provide greater insight into this complex system.

Seres Therapeutics Inc. a leading microbiome therapeutics platform company, announced on March 16th, 2017 plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the U.S. Food and Drug Administration (FDA). In a separate announcement today, Seres reported fourth quarter and full year 2016 financial results and provided an update on multiple ongoing microbiome clinical programs.

Seres plans to initiate a new SER-109 clinical study in approximately 320 patients with multiply recurrent C. difficile infection. Study participants will be randomized 1:1 between SER-109 and placebo. To ensure accurate measurement of C. difficile infection, diagnosis of recurrent C.difficile infection for both study entry and for endpoint analysis will be confirmed by C. difficile cytotoxin assay. Patients in the SER-109 arm will receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior ECOSPOR study. ECOSPOR III will evaluate patients for 24 weeks and the primary endpoint will compare the C. difficile recurrence rate in subjects who receive SER-109 verses placebo at up to eight weeks after dosing. The FDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressing FDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters.

“We are pleased to have received highly constructive guidance from the FDA regarding further SER-109 clinical development and we plan to initiate a new clinical study as soon as possible,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. “Our prior SER-109 studies provided important new biological and clinical data that have advanced our pioneering microbiome therapeutic efforts. Based on our learnings and dialogue with the FDA, we believe that we are now positioned to initiate a robust clinical study that may provide the basis for SER-109 approval. There is an urgent need for improved treatments for C. difficile infection, and we believe SER-109 has great potential to address the underlying cause of the disease and become the first approved microbiome therapeutic in this new field of medicine.”

About SER-109

SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state.

About Seres Therapeutics

Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. The Phase 2 study of Seres’ program SER-109 has been completed in multiply recurrent Clostridium difficile infection. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary CDI. For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding SER-109 development plans, the timing, design, and results of the ECOSPOR III study , the potential for ECOSPOR III to provide different results than the previous ECOSPOR study, the impact analysis of prior clinical studies may have on clinical outcomes, the potential for ECOSPOR III to qualify as a Pivotal Study, dysbiosis as an underlying cause of C. difficile and other diseases.

“Treating patients with recurrent C. difficile infection with microorganisms alone provides cure or reduction of symptoms at a rate many times higher than any drug or chemical that has ever been looked at. These cure rates of 94% and 96% are astronomical, and it is all due to the power of microbes, ” said Michael Sadowsky, PhD, Director of the BioTechnology Institute at the University of Minnesota, St. Paul, Minnesota.

“I think the future of medicine in the 21st century is to use the power of microbes to cure diseases.”

This new work, published in mBio, an open access journal of the American Society for Microbiology, has found which microbes are most effective in the fecal transplant procedure. The microbes from donor samples were purified and transplanted into patients to find which conferred the most benefit. The researchers used next-generation sequencing to assay the microbial populations of patients and donors.

Their findings surprised them; while they met expectations by curing around 90 percent of patients, some people who had received a placebo treatment, made up of their own fecal sample, were also cured. The researchers were able to determine that the patients cured by placebo already had some types of curative bacteria in their guts, strains that were boosted when they got the placebo.

“As opposed to what we thought, complete engraftment of microbiota is not required to cure a patient,” said Sadowsky.

“The study provides insight into which microorganisms are the most important for curing C. difficile and may allow clinicians to better tailor therapy, by improving donor material to facilitate a more rapid, effective, and lasting cure.”

Scientists can use this new data to optimize their treatments. “This paper provides us data with which microbes to supplement into our preparations,” Sadowsky concluded.

To read the article in its entirety click on the following link to be redirected:

The microbiome of patients admitted to the intensive care unit (ICU) at a hospital differs dramatically from that of healthy patients, according to a new study published in mSphere.

Researchers analyzing microbial taxa in ICU patients’ guts, mouth and skin reported finding dysbiosis, or a bacterial imbalance, that worsened during a patient’s stay in the hospital. Compared to healthy people, ICU patients had depleted populations of commensal, health-promoting microbes and higher counts of bacterial taxa with pathogenic strains – leaving patients vulnerable to hospital-acquired infections that may lead to sepsis, organ failure and potentially death.

What is dysbiosis? Pathogens, antibiotic use, diet, inflammation, and other forces can cause dysbiosis, a disruption in these microbial ecosystems that can lead to or perpetuate disease (1)

What makes a gut microbiome healthy or not remains poorly defined in the field. Nonetheless, researchers suspect that critical illness requiring a stay in the ICU is associated with the the loss of bacteria that help keep a person healthy. The new study, which prospectively monitored and tracked changes in bacterial makeup, delivers evidence for that hypothesis.
“The results were what we feared them to be,” says study leader Paul Wischmeyer, an anesthesiologist at the University of Colorado School of Medicine. “We saw a massive depletion of normal, health-promoting species.”
Wischmeyer, who will move to Duke University in the fall, runs a lab that focuses on nutrition-related interventions to improve outcomes for critically ill patients.

He notes that treatments used in the ICU – including courses of powerful antibiotics, medicines to sustain blood pressure, and lack of nutrition – can reduce the population of known healthy bacteria. An understanding of how those changes affect patient outcomes could guide the development of targeted interventions to restore bacterial balance, which in turn could reduce the risk of infection by dangerous pathogens.
Previous studies have tracked microbiome changes in individual or small numbers of critically ill patients, but Wischmeyer and his collaborators analyzed skin, stool, and oral samples from 115 ICU patients across four hospitals in the United States and Canada. They analyzed bacterial populations in the samples twice – once 48 hours after admission, and again after 10 days in the ICU (or when the patient was discharged). They also recorded what the patients ate, what treatments patients received, and what infections patients incurred.
The researchers compared their data to data collected from a healthy subset of people who participated in the American Gut project dataset. (American Gut is a crowd-sourced project aimed at characterizing the human microbiome by the Rob Knight Lab at the University of California San Diego.) They reported that samples from ICU patients showed lower levels of Firmicutes and Bacteroidetes bacteria, two of the largest groups of microbes in the gut, and higher abundances of Proteobacteria, which include many pathogens.
Wischmeyer was surprised by how quickly the microbiome changed in the patients. “We saw the rapid rise of organisms clearly associated with disease,” he says. “In some cases, those organisms became 95 percent of the entire gut flora – all made up of one pathogenic taxa – within days of admission to the ICU. That was really striking.” Notably, the researchers reported that some of the patient microbiomes, even at the time of admission, resembled the microbiomes of corpses. “That happened in more people than we would like to have seen,” he says.
Wischmeyer suggests the microbiome could be tracked like other vital signs and could potentially be used to identify patient problems and risks before they become symptomatic. In addition, now that researchers have begun to understand how the microbiome changes in the ICU, Wischmeyer says the next step is to use the data to identify therapies – perhaps including probiotics – to restore a healthy bacterial balance to patients.
Everyone who collaborated on the project – including dietitians, pharmacists, statisticians, critical care physicians, and computer scientists – participated on a largely voluntary basis without significant funding to explore the role of the microbiome in ICU medicine, says Wischmeyer.

To read this article in its entirety please click on the following link:

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